In recent years, the United States marketplace has seen an increasing appreciation of the health-promoting benefits of herbal preparations. Some people, however, have reservations about the use of herbal products due to the chemical complexity of such products and the perceived difficulty in ensuring batch-to-batch product reproducibility.

In order to address the concern, there has been a trend in the marketplace toward the use of "standardized" preparations. This paper describes the many factors that contribute to the proper standardization of a botanical product. The scope of the document covers a variety of preparations, from crude botanicals to solid oral dosages. This document is intended to foster a heightened awareness of the complexities associated with standardization, and to facilitate informed discussions between raw material suppliers, product manufacturers, practitioners, clinicians, regulators, and consumers.

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